Ethnic Differences in the Inflammatory Response in System... | NCT00284869

Studies
Ethnic Differences in the Inflammatory Response in Systemic Inflammation

NCT00284869

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Sep 13, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Endotoxemia

Interventions

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Jan 31, 2006

First Submission Date that Met QC Criteria

Jan 31, 2006

First Posted Date

Feb 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2006

Last Update Posted Date

Sep 13, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.

Detailed Description

Recent data show that there are significant disparities among genders and races in the incidence of sepsis. While men are consistently more likely to have sepsis than women, the apparent racial disparities are even more striking, approaching a doubling of the risk for sepsis among Afro-Americans. Most prominent is the risk among black men, the group in which sepsis occurs at the youngest age and results in the most deaths. Potential mechanisms for heterogeneous susceptibility to sepsis include genetic differences, which have been explored according to sex but not according to race, and other social and clinical factors.

The goal of this study is to explore whether proinflammatory and procoagulant responses in a well standardised inflammation model are comparable in healthy Caucasian and African volunteers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
LPS	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
Men aged >18 and <40 years
Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

Treatment with an investigational drug within three weeks prior to this trial
Participation in an LPS trial within the last 6 weeks
Hereditary deficiency of protein C or S, or a mutation of FV (Leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function
History of cardiovascular disease
Liver or kidney dysfunction
Regular use of medication or alcohol abuse
Use of any medication within three weeks prior to the first trial day
Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
Excessive sporting activities
Weight over 95 kg

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christa Firbas, MD	Medical University of Vienna, Department of Clinical Pharmacology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Dept. of Clinical Pharmacology		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16413239	Background	Leitner JM, Firbas C, Mayr FB, Reiter RA, Steinlechner B, Jilma B. Recombinant human antithrombin inhibits thrombin formation and interleukin 6 release in human endotoxemia. Clin Pharmacol Ther. 2006 Jan;79(1):23-34. doi: 10.1016/j.clpt.2005.10.003.

Measure	Description	Time Frame
neutrophil counts
IL-8
G-CSF

Measure	Description	Time Frame
various inflammation and coagulation parameters
Platelets
Adverse events

ID	Term
D016470	Bacteremia
D018805	Sepsis
D007239	Infections
D014115	Toxemia
D018746